Regulatory Affairs department

The regulatory affairs department will want to check that the report is fit for submission and also to identify any issues that need to be addressed before commissioning the expert report. 

Identification of key batch records These documents are then compared with the commitments that are contained in the Regulatory Commitment Document (see above). Any discrepancies identified are resolved, and explanations are documented when appropriate. This is done by the product development group in collaboration with the quality control and regulatory affairs departments. 

Ensure coordination among quality assurance, manufacturing and regulatory affairs departments concerning cGMP issues. 

One of our senior scientists was seconded to the Regulatory Affairs department in the Research organization to become conversant in the process for writing... 

Available from McNeil Specialty Products Company, Regulatory Affairs Department, 501 George Street, New Brunswick, NJ 08903-2400. 

In addition, any Field Sales instructions, Public Relations, Financial Analysts Statements and Press Releases should be reviewed for appropriateness and approved or modified. Such review will also involve both the Fegal and Regulatory Affair departments. Moreover, materials for medical liaison activities, communications to third party insurers and responses to other inquires should be reviewed prior to release. This is an important role, given the significance for the company and timeline pressures. 

As part of the regulatory affairs department, the quality assurance groups often call upon the medical information department to assist in ensuring that data used in any formal documentation that they review (from NDA submissions to changes in the package insert to new advertising campaigns) are accurate and appropriately used. 

Meanwhile, manufacturing scale-up and vahdation (both at the manufacturing and analytical level) activities are continued. Product purification, characterization and formulation are refined and tested for consistency and stability. At this point, next to the clinical development team, the role of the QA/QC and regulatory affairs departments are becoming increasingly important, making sure that GMP (Rules Governing Medicinal Products in the EU, Volume 4) and validation requirements are met... 

For other positions, even a Ph.D. and postdoctoral training cannot substitute for industrial research experience. A chemist needs experience to find work in a patent or regulatory affairs department. Patent coordinators (see text below), who are not lawyers but chemists, learn the basics of their future liaison positions as researchers whose inventions are patented. Their experience in assisting attorneys qualifies them to devote afi their efforts to such work. 

The toxicological and environmental issues for Phase 3 product candidate promotion are dependent upon the site of manufacture, product form, final end-use, and ultimate method of disposal. The Team Leader, along with a representative of the Regulatory Affairs Department, will ensure that the appropriate issues have been addressed and summarize the results in the Product Candidate Dossier for each product candidate that will be submitted for promotion to Phase 3. 

The team, in conjunction with a representative of the Regulatory Affairs Department, addresses any appropriate toxicological/Responsible Care issues required. The MRC shall advise the Product Team as early as possible during Phase 4 whether any imported raw materials, isolated intermediates manufactured during the production process, or the candidate product itself must be the subject of a premanufacture notice (PMN) prior to commercialization of the candidate product. If so, the Product Team shall estabhsh a timeline for gathering information required for submission of a PMN and for filing the PMN at least ninety days prior to anticipated commercial manufacture of the candidate product. If the MRC concludes that the PMN review period is likely to exceed ninety days, or that the candidate product is likely to... 

Dr. Zayas worked as a research scientist at a major New Jersey based pharmaceutical manufacturer, and then for the International Regulatory Affairs department, where she specialized in product registrations in Europe and Latin America. It was during this period that she utilized her scientific knowledge and her command of the Spanish language fo translate thousands of scientiflc documents. 

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